Screening with biomarkers for the early detection of Alzheimer’s disease

Not Applicable

• Conditions: Alzheimer's disease, dementia; Nervous System Diseases

• Registration Number: ISRCTN11126399
• Lead Sponsor: Stavanger University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-18
• Last Update Posted: 29 April 2024
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4615

Inclusion Criteria

Cohort 1:
1. Adults aged 50 years or above
2. Access to a computer (or touchscreen device) and the internet
3. Participant is willing and able to give informed consent for participation in the study
4. In the UK and Norway, already an active participant in the PROTECT-UK or PROTECT-Norge cohort respectively
5. Willing and able to visit one of the PREDICTOM research centres
6. Symptoms or risk profile indicating an increased risk of AD or related disorders, operationalized as having at least one of the below:
6.1. Subjective cognitive complaints
6.2. AD or dementia in a first-degree relative
6.3. At least one cardiometabolic disorder known to be a risk factor for dementia (e.g. diabetes, obesity, hypertension, hypercholesterolemia, cerebrovascular disease or coronary disease or peripheral arterial disease)

Cohort 2:
Criteria for high and low risk will be defined based on a machine learning algorithm based on retrospective data from existing datasets and refined with data from the Cohort 1 assessments and sampling. Thresholds will be set for high and low risk within a centralised dataset. The exact algorithm will be developed and completed prior to the first participant completing Level 1 testing. Criteria will include:
1. Relative risk scores for each of the 12 modifiable risk factors from the Lancet Commission (1)
2. Family history of dementia.
3. APOE genotype
4. Cognitive test performance from Cohort 1 testing
5. Blood biomarkers from finger prick blood test performed in Cohort 1
6. Data from other relevant Level 1 tests.
7. Willing and able to give informed consent for the Cohort 2 protocol

Exclusion Criteria

1. An established diagnosis of dementia
2. Life-threatening physical disease
3. Active major psychiatric disorder which is inconsistent with being able to complete informed consent or perform the procedures
4. Unable to speak native tongue
5. Neurodevelopmental disorder, sensory or other physical impairment or other factor making the person unable to complete the study procedures
6. Major disabling stroke, e.g., clinically significant symptoms and/or functional impairment

Study & Design

• Study Type: Observational
• Study Design: Not specified